Canadian Manufacturer Warned for Adulterated APIs
The FDA warned Montreal, Quebec-based drugmaker Les Produits Chimiques over serious quality unit failures that caused its APIs to be adulterated.
During a September 2017 inspection, the agency found multiple deficiencies in the quality unit’s performance in ensuring that the APIs were compliant with current good manufacturing practices.
Specifically, the firm didn’t keep samples bound for stability studies in temperature and humidity controlled storage areas. Instead, it kept them in a laboratory cabinet without monitoring the temperature and relative humidity.
Additionally, the firm had no controls in place to keep insects out of its packaging material storage area. At least twice, the investigator noted insects and spider webs in and on plastic-wrapped stacked containers used to package APIs.
The company also did not perform certain critical processes to ensure its powder API met manufacturing CGMPs. For example, the quality unit didn’t confirm that records included complete compliance test data before distributing an API batch. It also failed to document details like sample weight and preparation for various tests.
Multiple lots of powder API were distributed without the required release testing even though the products’ certificates of analysis said they met all required specifications. The investigator reviewed laboratory notebooks that did not support the COA claims that the products had passed identity tests.